Bluewater Medical Medical Device Development and Consultancy Services

Founded in 2014, Bluewater Medical is a global medical device development and consulting organisation, establishing products for orthopaedics, traumatology and spine surgery.

Our customers range from sole surgeon inventors to start-ups and global organisations. We offer services and expertise to develop a product from its original conception to design transfer into serial production and certification.

The added value is our extensive knowledge, a result of more than two decades of practical experience within the medical device industry, as well as a global network of suppliers and key opinion leaders.

Product development source and business link between medical device companies

Bluewater Medical acts as a connection between emergent start-up organisations and developed market players, allowing large players to benefit from the affiliation with start-ups in many ways. Contact with innovative technologies and widening the portfolio to increase profits are some of the main reasons for the relationship.

While this type of collaboration can sometimes fail, the primary reasons for this include the pre-mature phase of start-up, weak product-to-market fit, pricing or costs, and technology performance, which we can help companies to avoid.

Consistent client support

Large businesses frequently lack the capacities to bring innovative product conceptualisations into existence, as their internal resources are in place to advance the portfolio further, as prepared and estimated.

Bluewater Medical works seamlessly within our customers’ quality management systems (QMS), generating no integration borders or restrictions. In the past, we have often contributed to the improvement of the customer’s QMS system or were even an essential part of its creation.

Expertise from highly trained professionals

Our clients can benefit from our practical experience, as well as our global network of professionals within the medical industry.

Most of the employees at Bluewater Medical is a combination of senior development engineers, with a demonstrated reputation in creating and bringing medical devices to the market, finalised by fresher staff, who bring innovative methodologies to the table.

Bluewater Medical sees itself as contributors to ideas, as well as an integrated part of businesses, with a hands-on approach, proven to deliver quick results.

Support services for the medical device industry

Our continually increasing team provides support in:

• Mapping out user needs
• Risk management files
• Feasibility Studies
• Product development
• Introducing innovative technologies
• Decreasing manufacturing costs
• Increasing toughness and reliability
• Customisation
• Cadaver lab organisation
• Clinical evaluation planning
• Clinical evaluation reports
• Operative technique manuals